Extends dosing interval from 1 month to 3 months Developed using DongKook Pharmaceutical’s microsphere formulation technology Only 3‑month formulation for prostate cancer treatment in Korea… rising medical demand Aiming for marketing authorization this year and launch next year
DongKook Pharmaceutical announced on the 24th that it has successfully completed a Phase 3 clinical trial for its long-acting prostate cancer injectable treatment “Lorelin Depot Injection (ingredient name: leuprorelin)” in a 3‑month formulation (DKF-MA102).
The new 3‑month formulation injection was developed based on DongKook Pharmaceutical’s microsphere formulation technology. The company plans to complete the clinical study report for this product within the year, proceed with marketing authorization, and target product launch next year. Microsphere formulation technology is a drug delivery system in which the drug is released slowly in the body, enabling stable release of the drug for several weeks to several months after a single administration. DongKook Pharmaceutical first commercialized Lorelin Depot Injection in Korea using this technology in 1999. The 1‑month formulation has completed a domestic bioequivalence study and received confirmation from the Ministry of Food and Drug Safety (MFDS) in August last year that it is biologically equivalent to the original drug.
Lorelin Depot Injection works by suppressing the secretion of gonadotropin, thereby reducing blood testosterone and estrogen levels. In addition to prostate cancer, it is used as a treatment for hormone-related diseases such as endometriosis and precocious puberty. Currently, there is only one leuprorelin 3‑month formulation injection product on the Korean market. DongKook Pharmaceutical expects that the launch of its product will expand treatment options.
In October 2023, DongKook Pharmaceutical received approval for the DKF-MA102 investigational new drug (IND) application from the Ministry of Food and Drug Safety. The clinical trial was conducted in 161 patients with prostate cancer. At eight hospitals, including Ewha Womans University Mokdong Hospital, leuprorelin 11.25 mg was administered subcutaneously twice at 12‑week intervals.
The domestic market for leuprorelin formulations is estimated to be around KRW 80 billion. The global market is reported to be around KRW 5 trillion.
An official at DongKook Pharmaceutical said, “The 3‑month formulation of Lorelin Depot Injection is expected to improve treatment convenience and quality of life for patients going forward.”
Kim Min-beom
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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